The Efficacy of Continuous Cold-Therapy on Postoperative Pain and Narcotics Use Following Spinal Fusion

Degenerative Disc Disease Clinical Trial

Official title:

The Efficacy of Continuous Cold-Therapy on Postoperative Pain and Narcotics Use Following Spinal Fusion

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03640338
• Other study ID #: 18050401
• Status: Withdrawn
• Phase: N/A
• Start date: April 2020
• Est. completion date: December 2020

Study information

• Verified date: November 2020
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patient outcomes and satisfaction are an ever-increasing priority in surgical specialties. Cryotherapy has been utilized following spine surgery as an adjunct therapy to reduce postoperative inflammation and improve patient outcomes. However, limited studies have investigated the effect of cryotherapy on postoperative pain and narcotics use. Fountas et al. performed a randomized controlled trial to assess the impact of postoperative cryotherapy following single-level lumbar microdiscectomy. The authors reported patients receiving cryotherapy required significantly less pain medication (0.058 mg/kg/hr versus 0.067 mg/kg/hr, p<0.001) and had shorter hospital stays (1.71 days versus 2.65 days, p<0.001) as compared to the control group. In another randomized trial of single-level lumbar discectomy patients, Murata et al. demonstrated cryotherapy to have no significant effect on VAS inpatient pain scores or postoperative blood loss.

Description:

The purpose of this study is to determine if postoperative cryotherapy with a cold-therapy system reduces postoperative pain and narcotic consumption following single and multi-level spinal fusion.

The investigators hypothesize that patients undergoing lumbar spinal fusion who receive postoperative cryotherapy treatment with a cold-therapy system will have reduced inpatient pain scores and require less narcotics as compared to patients that receive standard care (ice pack).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Single or multi-level lumbar spinal fusion for degenerative pathology, including:

radiculopathy, central spinal stenosis, foraminal stenosis, herniated nucleus pulposus, degenerative disc disease, and isthmic or degenerative spondylolisthesis.

2. Patient able to provide informed consent

Exclusion Criteria:

1. Chronic preoperative narcotic use defined as daily narcotic use for the past 6 months prior to surgery

2. Workers' compensation insurance claim

3. Active or history of malignancy

4. Unable to speak, read, or comprehend English language

Related Conditions & MeSH terms

• Central Spinal Stenosis
• Constriction, Pathologic
• Degenerative Disc Disease
• Degenerative Spondylolisthesis
• Foraminal Stenosis
• Herniated Nucleus Pulposus
• Intervertebral Disc Degeneration
• Isthmic Spondylolisthesis
• Pain, Postoperative
• Radiculopathy
• Spinal Stenosis
• Spondylolisthesis

Intervention

Device:
• Cold-Therapy System
After surgery, participants assigned to this group will receive the cold-therapy system to use at the hospital and during the first 2 weeks following discharge.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain	Average daily Visual Analog Scale (VAS) survey, which measures pain, for the duration of hospital stay and postoperative VAS scores will be recorded for 2 years postoperatively. This information will be collected through a survey that will be administered upon patient discharge. Patients will be asked to return the completed survey to the research team.; VAS scale ranges from 0 - 100 mm, with 100 representing maximum pain and 0 representing no pain.	2 year postoperative
Primary	Narcotics Consumption	Total, daily, and hourly narcotics consumption during the hospitalization. Narcotic consumption will be recorded for 2 weeks following discharge. Patients will be asked to report the number of narcotic pills taken each day. This information will be collected through a survey that will be administered upon patient discharge. Patients will be asked to return the completed survey to the research team.	2 weeks postoperative
Secondary	Bony fusion	Postoperative radiographs and CT scan will be used to assess fusion.	2 year postoperative
Secondary	Disability	Postoperative Oswestry Disability Index (ODI) survey scores will be compared to preoperative values.; ODI measures disability for lumbar patients. The scale ranges from 0% to 100%. 0-20% represents minimal disability, 21-40% represents moderate disability, 41-60% represents severe disability, 61%-80% represents a crippled state, and 81-100% represents a bed-bound patient.	2 year postoperative
Secondary	Physical Function: Patient-Reported Outcomes Measurement Information System (PROMIS)	Postoperative PROMIS scores will be compared to preoperative values.; PROMIS evaluates physical function through a series of questions covering level of difficulty with normal daily activities. A score of 5 represents "without any difficulty" and a score of 1 represents "unable to do".	2 year postoperative
Secondary	General Health Status: Short-Form (SF-12)	Postoperative SF-12 scores will be compared to preoperative values.; SF-12 evaluates the general health status of the patient. A minimum score of 0 represents the lowest level of health, while a maximum score of 100 represents the highest level of health.	2 year postoperative
Secondary	Length of Stay	The number of hours of hospitalization from entering the recovery room (time zero) until patient meets discharge criteria.	Up to 2 weeks
Secondary	Disposition on discharge	This outcome evaluates where the patient will return to after their inpatient stay. This could include, but is not limited to, their home, a rehabilitation facility, or a skilled nursing facility.	Up to 2 weeks